Roche Recalls Lots of Coaguchek Xs Pt Test Strips with FDA’s Class I Warning

Shots:

• The recall is in response to the inaccurate INR (International Normalized Ratio) results reported byCoaguChek XS PT Test Strips distributed by Terrific Care/Medex Supply including catalogue number that were not included in Roche’s 2018, recall of strips and were not labeled or authorized for sales in the US
• The FDA Class I recall is for the devices which have serious or harmful effect on the human body leading to death
• CoaguChek XS PT Test Strips are used in combination with CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS PST and CoaguChek Vantus test meter devices for monitoring levels of warfarin to examine time taken for blood to clot

Click here to read full press release/ article | Ref: FDA | Image: Irish Times